Handheld medical devices face numerous hurdles on the way to market. First, they need to obtain FDA 510(K) pre-marketing approval for safety and effectiveness. Then, they must be manufactured to the ...

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...

The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

Nevada Sanchez, co-founder of Butterfly Network, talks to Machine Design about the organization making life-saving technology available to frontline healthcare workers in the developing world. In ...

Devices used in laboratories, hospitals and similarly high-demand settings must remain consistently accurate to encourage trust in the parties using them for critical tasks. However, overheating can ...